FDA approves new usage for Biohaven's migraine drug

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The federal Food and Drug Administration on Thursday has approved a migraine headache drug made by New Haven-based Biohaven as a preventative medicine in addition to a treatment for the malady.

With that approval, Biohaven’s drug Nurtec ODT can be used to treat episodic migraines after they have occurred as well as a preventative treatment. The FDA first approved Nurtec as a treatment for migraines in February 2020.

FDA officials weren’t available for comment on Friday regarding whether Nurtec ODT is the first and only drug that the agency has approved for both treating existing migraines as well as preventing future ones.

Dr. Eric Baron, a leading neurologist with the Cleveland Clinic, tweeted Thursday that Nurtec ODT “makes history as the first medicine FDA approved as both a migraine abortive and preventive.”

The medication is taken orally, which makes it different than migraine preventatives already on the market that are administered to patients through injections.

Migraine headaches are the third most prevalent illness in the world; the World Health Organization classifies them as one of the 10 most disabling medical illnesses. Approximately 40 million people in the U.S. — and hundreds of millions worldwide — suffer from migraines.

Migraine headaches are defined as debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches with moderate to severe pain; nausea or vomiting; and a sensitivity to light or sound.

Vlad Coric, Biohaven’s chief executive officer, said the ability to use Nurtec for treatment and prevention “makes for a paradigm shift” in how to deal with migraines.

“I think you’re going to see doctors and patients use Nurtec ODT now in a very flexible and customizable way,” Coric said.

Peak sales of Nurtec ODT are projected to exceed $1 billion a year in revenues, he said, which would put it in what is known in the pharmaceutical category as “a blockbuster drug.” The first ever blockbuster drug, an ulcer medication called Tagament, reached the market in 1977 and earned its creators a Nobel Prize, according to pharmaphorum, a drug industry web site.

Coric said Biohaven will market Nurtec ODT using a combination of celebrity migraine sufferers as well as average individuals. One of the first commercials that will appear promoting the Nurtec ODT’s dual capabilities will feature actress Whoopi Goldberg.

Coric said that 85 percent of those who suffer from migraine headaches are women, who first begin suffering from the problem in their teenage years.

Dr. Peter Goadsby, a professor of neurology at UCLA and the recipient of the 2021 Brain Prize for his groundbreaking migraine research, said Nurtec ODT’s ability to both treat and prevent migraines “is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine.”

The most common side effects of Nurtec ODT are nausea, stomach pain or indigestion. The drug may cause serious side effects such as allergic reactions, including trouble breathing and rash.